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Trial of Juvista (Avotermin) Following Removal of Ear Lobe Keloid Scars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00469235
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : September 16, 2009
Sponsor:
Information provided by:
Renovo

Tracking Information
First Submitted Date  ICMJE May 3, 2007
First Posted Date  ICMJE May 4, 2007
Last Update Posted Date September 16, 2009
Study Start Date  ICMJE June 2007
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
Frequency of adverse events [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2008)
Keloid reoccurrence [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
Keloid re-occurrance [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Juvista (Avotermin) Following Removal of Ear Lobe Keloid Scars
Official Title  ICMJE A Single-centre, Double Blind, Randomised, Rising Dose Tolerance Study to Investigate the Safety of Juvista When Administered Following Excision of Ear Lobe Keloids.
Brief Summary This trial will assess the safety and efficacy of 50 and 200ng Juvista per linear cm of wound margin administered by intradermal injection following the excision of keloid scars on the ear lobe. Ear lobe keloids commonly occur after ear piercing and can be particularly distressing for patients as they are very difficult to conceal and are usually bilateral. As the recurrence rate and growth rate of keloids can vary significantly between individuals, trial subjects will have bilateral ear lobe keloids and will act as their own control. One ear lobe will be treated with Juvista following keloid excision and one with placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Keloid
Intervention  ICMJE Drug: Avotermin

10 patients:- 50ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure.

10 Patients:- 200ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure.

Study Arms  ICMJE
  • Placebo Comparator: 1
    50ng dose group
    Intervention: Drug: Avotermin
  • Placebo Comparator: 2
    200ng dose group
    Intervention: Drug: Avotermin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2007)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged 18-85 years who have given written informed consent.
  • Patients with bilateral ear lobe keloid scars suitable for surgical excision which will result in a single wound on each ear lobe no greater than 2cm long and restricted to the skin, fat and fibrous tissue of the ear lobe.
  • Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol.
  • Female patients of child bearing potential who are using a highly effective method(s) of contraception and agree to do so from at least the screening visit until one month after administration of the final study dose.

Exclusion Criteria:

  • Patients who have had ear lobe keloids treated with irradiation, cryosurgery, corticosteroids, or other pharmacological agents in the three months prior to the first trial dose administration.
  • Patients with a history of a bleeding disorder.
  • Patients who on direct questioning and/or physical examination have past or present evidence of eczema or psoriasis local to the site of administration, uncontrolled diabetes (fasting plasma glucose concentration consistently at or above 7.0mmol 1-1 (126 mg dl-1), severely immunocompromised patients and/or malignant skin tumours e.g. melanomas, squamous or basal cell carcinomas.
  • Patients with a skin disorder, not related to the keloid disease, that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial
  • Patients with a history of malignancy in the last 5 years.
  • Patients with a history of hypersensitivity to any of the drugs or dressings used in this trial.
  • Patients who are taking, or have taken any investigational product or participated in a clinical trial in the three months prior to first trial dose administration.
  • Patients undergoing investigations or changes in management for an existing medical condition.
  • Patients who, in the opinion of the Investigator, are unlikely to complete the trial for whatever reason.
  • Female patients who are pregnant or lactating.
  • Patients with a creatinine clearance (CLcr) of 80ml/min or less.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00469235
Other Study ID Numbers  ICMJE RN1001-0064
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Renovo Ltd
Study Sponsor  ICMJE Renovo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leroy Young, MD Body Aesthetic Plastic Surgery and Skincare Centre
PRS Account Renovo
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP